(273 days)
Bander Ureteral Diversion Stent Set: Used for intraoperative placement to stent the ureter and provide drainage of urine from the kidney to the external stoma during ureteroileal conduit construction and continent urinary diversions.
Dretler Ureteroscopy Stent Set: This device is intended for post-ureteroscopy stenting of the ureter.
The Bander Ureteral Diversion Stent Set features a pigtail ureteral stent constructed of either silicone or polyurethane. The stent ranges from 4.7 to 8.4 French and the overall lengths range from 70 to 90 centimeters. The pigtail retention coil can be open or closed, tapered or nontapered, but all configurations contain 6 evenly space sideports continue for the first 10 centimeters of the stent body from the pigtail. In addition to the 90° rotated sideports, some of the stents feature ink markings to aid in placement. The Bander Ureteral Diversion Stents Sets are supplied with either one or two stents. When two stents are included, a right and left are color-coded red and blue, respectively. The Bander Ureteral Diversion Stent Sets are also supplied with a straight wire guide. The accessories supplied with the Bander Ureteral Diversion Stent Sets include an adapter with an O-ring and a catheter retainer.
The Dretler Ureteroscopy Stent Set includes a 4.7, 6.0, or 8.4 French stent is manufactured using a polyurethane material and has a single pigtail at the distal end with 3 evenly spaced sideports. The stent comes with incremental ink markings and is 125 centimeters in length. The Dretler Ureteroscopy Stent Sets are supplied with an accessory connector with an O-ring and a wire guide.
The provided document is a 510(k) summary for the Bander Ureteral Diversion Stent Set and Dretler Ureteroscopy Stent Set. It describes the devices, their intended use, and compares them to a predicate device to demonstrate substantial equivalence.
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical form. Instead, the document indicates that various tests were performed to ensure "reliable design and performance under the specified testing parameters" and to meet "design input requirements based on the intended use." The reported device performance is that the devices "met the design input requirements."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reliable Design | Subject devices met design input requirements. |
| Reliable Performance under specified testing parameters | Subject devices met design input requirements. |
| MRI Safety | Testing conducted, results suggest acceptable performance. |
| Dimensional Accuracy | Testing conducted, results suggest acceptable performance. |
| Tensile Strength | Testing conducted, results suggest acceptable performance. |
| Shaft and Curl Elongation | Testing conducted, results suggest acceptable performance. |
| Retention Strength | Testing conducted, results suggest acceptable performance. |
| Flow Rate | Testing conducted, results suggest acceptable performance. |
| Radiopacity | Testing conducted, results suggest acceptable performance. |
| Kink Resistance | Testing conducted, results suggest acceptable performance. |
| Compatibility with components | Testing conducted, results suggest acceptable performance. |
| Artificial Urine Soak (Biocompatibility/Material Integrity) | Testing conducted, results suggest acceptable performance. |
| Accelerated Aging (Shelf-life) | Testing conducted, results suggest acceptable performance. |
| Packaging integrity (for Tyvek polyethylene peel-open pouch) | Testing conducted, results suggest acceptable performance. |
| Sterilization effectiveness (EtO) | Testing conducted, results suggest acceptable performance. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the conducted tests. It only lists the types of tests performed (e.g., MRI Safety Testing, Dimensional, Tensile Strength, etc.).
No information is provided regarding the provenance (country of origin, retrospective or prospective) of any data beyond the tests being conducted internally by Cook Incorporated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided document. The document describes engineering and material performance tests, not studies requiring expert clinical interpretation or ground truth establishment in a medical context.
4. Adjudication method for the test set
This information is not available in the provided document. As mentioned above, the tests are primarily engineering performance tests, not clinical studies requiring adjudication of outcomes or interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC comparative effectiveness study, an AI component, or human reader improvement in this document. This document is for a ureteral stent, a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication of any algorithm-only or AI performance testing. This document is for a physical medical device.
7. The type of ground truth used
For the engineering and material tests listed, the "ground truth" would be established by physical measurements, standardized testing procedures, and material specifications. For example, for "Dimensional" testing, the ground truth would be the expected dimensions based on design specifications. For "Tensile Strength," the ground truth would be the strength requirements described in internal design documents or relevant material standards.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document pertains to a physical medical device and does not involve machine learning or training sets.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).